FDA 510(k) Application Details - K171774

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K171774
Device Name	Barrier, Synthetic, Intraoral
Applicant	Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79 Lubbock, TX 79424 US Other 510(k) Applications for this Company
Contact	Shane Shuttlesworth Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2017
Decision Date	10/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review